@pipeworx/ema-article57

EMA Article 57 product data — every medicine with a valid marketing authorisation anywhere in the European Economic Area (centrally, mutual-recognition, decentralised AND purely nationally authorised), one row per product x authorisation-country, with the marketing-authorisation holder and pharmacovigilance system location for each. Keyless.

Part of Pipeworx — an MCP gateway connecting AI agents to 1863+ live data sources. This is an independent, unofficial integration — not affiliated with, endorsed by, or published by the upstream provider.

This is EMA's WIDE register. The sibling ema-medicines pack covers only the EU centralised-procedure medicines (~1 row per medicine, richer fields — status, indications, approval dates). Article 57 is the opposite trade-off: thinner fields, but every EEA country's nationally authorised products too, which ema-medicines explicitly does not carry.

Tools

• ema_article57_search(query?, active_substance?, holder?, country?, route?, limit?, offset?) — free-text/filtered search with real offset+limit pagination and a total_matches count. Answers "which EEA countries is X authorised in", "who is the marketing-authorisation holder for X in country Y", "which products does company Z hold in the EEA".
• ema_article57_product(name, country?) — every authorisation-country record for one product by name (exact match preferred, falls back to substring with match_type marked). Article 57 carries no indication text and no per-product URL, so this returns the authoritative EMA source document URL instead of a paraphrased indication.
• ema_article57_recent_changes(since) — products added to / removed from the register since a date, computed by diffing this pack's own dated snapshots (the source has no change-date column at all — see Gotchas). Returns comparable: false with a stated reason rather than a guessed empty diff when no snapshot covers the requested window.
• ema_article57_dataset_info() — the authoritative EMA bulk-download URL, current row count, this pack's snapshot dates on record, and the full list of distinct authorisation-country values (for exact spelling before filtering by country).

Auth

Keyless.

Data sources

• https://www.ema.europa.eu/en/documents/other/article-57-product-data_en.xlsx — the Article 57 database export, linked from EMA's "Public data from Article 57 database" page. Verified live 2026-09-25: HTTP 200, Last-Modified: Thu, 24 Sep 2026 13:38:24 GMT, 7,870,020 bytes, 164,314 data rows. The page states the file carries "EMA/518502/2018 Rev. 88" and is updated "periodically" — there is no published cadence, so Last-Modified is the only real freshness signal.

Architecture — this pack does NOT fetch EMA live

Measured 2026-09-25 against the real file: 7.87 MB compressed unzips to 63.0 MB of sheet1.xml + 4.7 MB of sharedStrings.xml (164,314 rows x 8 columns). Parsing a much smaller EMA export with the same regex-scan approach (ema-medicines's ~0.9 MB report) already measured 123 MB of V8 heap; this file is ~9x bigger and would not fit in a Cloudflare Worker's 128 MB ceiling. So this pack reads a pre-built, pre-compacted dataset from the shared pipeworx-datasets R2 bucket instead of calling EMA per request. scripts/ingest-ema-article57.mjs does the actual fetch + XLSX parse (offline, not in a Worker) and writes:

• ema-article57/latest.json.gz — all 164,314 rows, dictionary-encoded (schema 2: each column is a table of unique strings plus one integer index per row), 6.35 MB raw / 1.42 MB gzipped, read once per isolate.

  Why columns, not row objects: schema 1 stored one object per row (29 MB of JSON) and three of the four tools died with Cloudflare error 1102 (resource limits) inside the gateway isolate on 202

... View full README on GitHub